Trial · NCT01341639
Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007)
NCT01341639, Phase 3, Completed, MCM Vaccines B.V.; results first posted 2019-04-10
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007). Trials, record NCT01341639. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01341639
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007)
- NCT number
- NCT01341639
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,250 participants, actual
- Lead sponsor
- MCM Vaccines B.V.
- Conditions
- Bacterial Infections, Virus Diseases
- Interventions
- V419, INFANRIX™ hexa, RotaTeq, Prevenar 13, ProQuad™
- First posted
- 2011-04-26
- Last updated
- 2019-04-30
- Other registries' IDs
- eudract:2010-021490-37
- Results first posted
- 2019-04-10
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months | One month after post-dose 3 of PRI5 (5 months old) | Antibody titres in the PR5I group were measured by Radioimmunoassay (RIA) for Haemophilus influenzae type b (PRP), Micrometabolic inhibition test (MIT) for diphtheria \& poliovirus, and Enzyme-Linked Immunosorbent Assay (ELISA) for tetanus. Percentage of participants with an Ab titre ≥0.15 μg/mL for Haemophilus influenzae type b (Hib) (polyribosylribitol phosphate, PRP); ≥0.01 IU/mL; for diphtheria \& tetanus; ≥8 (1/dil) for inactivated poliovirus types 1, 2 \& 3 (IPV1, 2 \& 3) are reported. 95% confidence interval (CI) were calculated based on the exact binomial method by Clopper and Pearson. The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the predetermined lower CI limits for PRP, diphtheria (80%), tetanus (90%), and IPV1, 2 \& 3 (90%). |
| Primary | Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months | One month after Toddler dose of PRI5 (13 months old) | Antibody titres in the PR5I group were measured by RIA for PRP, MIT for diphtheria \& poliovirus, enhanced Chemiluminescence assay (ECi)) for Hepatitis B surface antigen (HBsAg) and ELISA for tetanus, Pertussis toxoid (PT), Filamentous haemagglutinin (FHA), Fimbriae types 2 \& 3 (FIM) \& Pertactin (PRN). Percentage of participants with an Ab titre ≥1.0 μg/mL for Hib (PRP); ≥0.1 IU/mL; for diphtheria \& tetanus; ≥10 mIU/mL HBsAg; ≥8 (1/dil) for IPV1, 2 \& 3, and seroresponse to PT, FHA, FIM and PRN are reported. 95% confidence interval (CI) were calculated based on the exact binomial method by Clopper and Pearson. The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the lower CI limits for PRP, PT, FHA, FIM, and PRN (75%); Diphtheria (80%); HBsAG, IPV 1, 2, 3 (90%). |
| Primary | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months | One month after post-dose 3 of PRI5 (5 months old) | Antibody titres were measured by RIA for PRP, MIT for diphtheria \& poliovirus, and ELISA for tetanus. Percentage of participants with an Ab titre ≥0.15 μg/mL for Hib) (PRP); ≥0.01 IU/mL; for diphtheria \& tetanus; ≥8 (1/dil) for inactivated poliovirus types 1, 2 \& 3 (IPV1, 2 \& 3) are reported. The estimated response rates are based on the method by Miettinen and Nurminen stratified by country. |
| Primary | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response Rates to Hepatitis B and Seroresponse to Pertussis Antigens Pt, FHA and PRN One Month After the Toddler Dose at 13 Months Old | One month after Toddler dose of PRI5 (13 months old) | Antibody titres were measured by ECi for HBsAg and ELISA for PT, FHA, \& PRN. Percentage of participants with an Ab titre ≥10 mIU/mL HBsAg; ≥8 (1/dil) for IPV1, 2 \& 3, and seroresponse to PT, FHA, and PRN are reported. The estimated response rates are based on the method by Miettinen and Nurminen stratified by country. |
| Secondary | Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old | One month after Toddler dose of PRI5 (13 months old) | Ab titres were measured by ELISA, excepting the Ab to varicella which was determined by glycoprotein ELISA. Percentage of participants with an Ab titre ≥255 mIU/mL for measles, ≥10 Ab units/mL for mumps, ≥10 IU/mL for rubella, and ≥5 gpELISA units/mL for varicella are reported. 95% CI were calculated based on the exact binomial method by Clopper and Pearson. The immune response to ProQuad vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the predetermined lower CI limits: 90% for measles, mumps \& rubella, and 76% for varicella. |
| Secondary | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old | One month after Toddler dose of PRI5 (13 months old) | Ab titres were measured by ELISA, excepting the Ab to varicella which was determined by glycoprotein ELISA. Percentage of participants with an Ab titre ≥255 mIU/mL for measles, ≥10 Ab units/mL for mumps, ≥10 IU/mL for rubella, and ≥5 gpELISA units/mL for varicella are reported. The estimated response rates are based on the method by Miettinen and Nurminen stratified by country. |
| Secondary | Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination | Day 1 to Day 15 after any vaccination | Global safety was assessed by measuring injection-site and systemic AEs reported daily on the Vaccination Report Card (VRC) by the parent(s) or legal representative from Day 1 to Day 15 (D1-D15) after each hexavalent vaccination. Solicited injection-site and systemic AEs were reported daily from Day 1 to Day 5 (D1-D5) after each hexavalent vaccination. AEs at injection sites were always considered as vaccine-related (Injection-Site Reactions (ISRs)). The investigator assessed whether systemic AEs were related (V-related) or not to the vaccine. All AEs (related and unrelated) are reported. |
| Secondary | Percentage of Participants Reporting Solicited ISRs From Day 1 to Day 5 After Any Vaccination | Day 1 to Day 5 after any vaccination | Solicited ISRs were defined as injection-site erythema, injection-site pain, and injection-site swelling occurring from Day 1 (D1) to Day 5 (D5) after vaccination. AEs at injection sites were always considered as vaccine-related (Injection-Site Reactions (ISRs)). |
| Secondary | Percentage of Participants Reporting Unsolicited ISRs From Day 1 to Day 15 After Any Vaccination | Day 1 to Day 15 after any vaccination | Unsolicited ISRs with incidence ≥1% after any vaccination were reported daily on the VRC by the parent(s) or legal representative from (D1-D15). AEs at injection sites were always considered as vaccine-related ISRs |
| Secondary | Percentage of Participants Reporting Solicited Systemic AE From Day 1 to Day 5 After Any Vaccination | Day 1 to Day 5 after any vaccination | Solicited systemic AEs were defined as crying, decreased appetite, irritability, pyrexia (rectal temperature ≥38.0°C), somnolence, and vomiting occurring from D1 to D5 after vaccination. The investigator assessed whether these systemic AEs were related or not to the vaccines. All (related and unrelated) AEs are reported. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months | One month after post-dose 3 of PRI5 (5 months old) | All participants in the PR5I group who met inclusion criteria, were not protocol violators, received vaccinations within acceptable day ranges, and who had serology results within revised windows (RW) of Days 28 to 51 Post-Dose 3. Participants from site 0048 were excluded. Participants in the INFANRIX™ hexa group were not analyzed. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months | One month after Toddler dose of PRI5 (13 months old) | All participants in the PR5I group who met inclusion criteria, were not protocol violators, received vaccinations within acceptable day ranges, and who had serology results within RW of Days 28 to 51 Post-Toddler dose. Participants from site 0048 were excluded. Participants in the INFANRIX™ hexa group were not analyzed for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months | One month after post-dose 3 of PRI5 (5 months old) | All participants who met inclusion criteria, were not protocol violators, received vaccinations within acceptable day ranges, and who had serology results within RW of Days 28 to 51 Post-Dose 3. Participants from site 0048 were excluded. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response Rates to Hepatitis B and Seroresponse to Pertussis Antigens Pt, FHA and PRN One Month After the Toddler Dose at 13 Months Old | One month after Toddler dose of PRI5 (13 months old) | All participants who met inclusion criteria, were not protocol violators, received vaccinations within acceptable day ranges, and who had serology results within RW of Days 28 to 51 Post-Toddler dose. Participants from site 0048 were excluded. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old | One month after Toddler dose of PRI5 (13 months old) | All participants in the PR5I group who met inclusion criteria, were not protocol violators, received vaccinations within acceptable day ranges, and who had serology results within RW of Days 28 to 51 Post-Toddler dose. Participants from site 0048 were excluded. Participants in the INFANRIX™ hexa group were not analyzed for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old | One month after Toddler dose of PRI5 (13 months old) | All participants who met inclusion criteria, were not protocol violators, received vaccinations within acceptable day ranges, and who had serology results within RW of Days 28 to 51 Post-Toddler dose. Participants from site 0048 were excluded. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination | Day 1 to Day 15 after any vaccination | All randomised participants who received at least 1 vaccination and who had safety follow-up. Participants from site 0048 were excluded. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Reporting Solicited ISRs From Day 1 to Day 5 After Any Vaccination | Day 1 to Day 5 after any vaccination | All randomised participants who received at least 1 vaccination and who had safety follow-up. Participants from site 0048 were excluded. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Reporting Unsolicited ISRs From Day 1 to Day 15 After Any Vaccination | Day 1 to Day 15 after any vaccination | All randomised participants who received at least 1 vaccination and who had safety follow-up. Participants from site 0048 were excluded. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Reporting Solicited Systemic AE From Day 1 to Day 5 After Any Vaccination | Day 1 to Day 5 after any vaccination | All randomised participants who received at least 1 vaccination and who had safety follow-up. Participants from site 0048 were excluded. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group95
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months | PR5I | Anti-PRP ≥0.15 μg/mL | 98.36 | 95% Confidence Interval 96.92 to 99.25 | Percentage of participants |
| Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months | PR5I | Anti-Diphtheria ≥0.01 IU/mL | 99.82 | 95% Confidence Interval 98.98 to 100 | Percentage of participants |
| Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months | PR5I | Anti-Tetanus ≥0.01 IU/mL | 100 | 95% Confidence Interval 99.32 to 100 | Percentage of participants |
| Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months | PR5I | Anti-IPV1 ≥8 (1/dil) | 100 | 95% Confidence Interval 99.33 to 100 | Percentage of participants |
| Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months | PR5I | Anti-IPV2 ≥8 (1/dil) | 99.82 | 95% Confidence Interval 98.99 to 100 | Percentage of participants |
| Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months | PR5I | Anti-IPV3 ≥8 (1/dil) | 100 | 95% Confidence Interval 99.33 to 100 | Percentage of participants |
| Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months | PR5I | Anti-PRP ≥1.0 μg/mL | 94.99 | 95% Confidence Interval 92.51 to 96.83 | Percentage of participants |
| Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months | PR5I | Anti-Diphtheria ≥0.1 IU/mL | 99.81 | 95% Confidence Interval 98.96 to 100 | Percentage of participants |
| Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months | PR5I | Anti-Tetanus ≥0.1 IU/mL | 100 | 95% Confidence Interval 99.3 to 100 | Percentage of participants |
| Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months | PR5I | Anti-IPV1 ≥8 (1/dil) | 99.81 | 95% Confidence Interval 98.97 to 100 | Percentage of participants |
1 to 10 of 95Source ClinicalTrials.gov
See all 95 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Infant Series | STARTED | PR5I | 628 | |
| Infant Series | STARTED | INFANRIX™ Hexa | 622 | |
| Infant Series | Site 0048 Excluded | PR5I | 611 | |
| Infant Series | Site 0048 Excluded | INFANRIX™ Hexa | 606 | |
| Infant Series | Treated | PR5I | 610 | |
| Infant Series | Treated | INFANRIX™ Hexa | 605 | |
| Infant Series | COMPLETED | PR5I | 599 | |
| Infant Series | COMPLETED | INFANRIX™ Hexa | 590 | |
| Infant Series | NOT COMPLETED | PR5I | 29 | |
| Infant Series | NOT COMPLETED | INFANRIX™ Hexa | 32 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events92
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Conjunctivitis | Eye disorders | PR5I | 20 | 610 | 23 |
| other | Conjunctivitis | Eye disorders | INFANRIX Hexa | 32 | 605 | 36 |
| other | Diarrhoea | Gastrointestinal disorders | PR5I | 98 | 610 | 129 |
| other | Diarrhoea | Gastrointestinal disorders | INFANRIX Hexa | 84 | 605 | 113 |
| other | Flatulence | Gastrointestinal disorders | PR5I | 45 | 610 | 55 |
| other | Flatulence | Gastrointestinal disorders | INFANRIX Hexa | 39 | 605 | 50 |
| other | Vomiting | Gastrointestinal disorders | PR5I | 205 | 610 | 328 |
| other | Vomiting | Gastrointestinal disorders | INFANRIX Hexa | 194 | 605 | 333 |
| other | Crying | General disorders | PR5I | 523 | 610 | 1,543 |
| other | Crying | General disorders | INFANRIX Hexa | 531 | 605 | 1,482 |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PR5I | 0 | 610 |
| Total, all-cause mortality | INFANRIX Hexa | 0 | 605 |
| Total, other adverse events | PR5I | 603 | 610 |
| Total, other adverse events | INFANRIX Hexa | 599 | 605 |
| Total, serious adverse events | PR5I | 23 | 610 |
| Total, serious adverse events | INFANRIX Hexa | 22 | 605 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27846055 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| PR5I vs INFANRIX Hexa: deaths from any cause | Trial comparisons |
| PR5I vs INFANRIX Hexa: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01341639
GET https://conductscience.org/api/trials/v1/NCT01341639/results?page=2